FDA session aims to clarify rules on food safety

April Mackie, director of food safety and regulatory compliance for Ramco Enterprises Inc. in Salinas, left, talks to Josh Rolph of the California Farm Bureau Federation, center, and walnut grower Joe Ferrari of Linden about the changes in proposed food-safety rules at an FDA listening session in Sacramento.
Photo/Christine Souza

Some details about the Food Safety Modernization Act became clearer, after farm groups participated in a listening session that focused on updated proposed rules for enacting the food-safety law.

The session, held by the U.S. Food and Drug Administration in Sacramento last week, was hosted by the California Department of Food and Agriculture and sponsored by organizations including the California Farm Bureau Federation.

FDA officials discussed revisions released in late September for three proposed rules, including the rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption—known as the produce safety rule—plus rules on manufacturing practices and hazard analysis for human food and for animal food.

Agency experts provided technical information, clarifying details in the proposals, which were updated to address comments the FDA received from the public. Since the act was signed in January 2011, the FDA has proposed seven rules to implement it. The agency will issue final rules in 2015.

"Based upon the revisions made in the supplemental rules, it is fair to say that the FDA listened to California agriculture and made changes that made more sense," said Josh Rolph of the CFBF Federal Policy Division. "We still have questions and concerns that will be reflected in our comments, which are due in December. There are other outstanding issues that were not addressed in the supplemental rules that we hope will be cleared up in the final rule issued next year."

During the listening session, Joy Johanson of the FDA Office of Food Safety provided information on agricultural water standards in the produce safety rule and the frequency of water testing.

"We received many comments on this, including that it (the water standard) was more restrictive than would have been necessary for public health, that it was more suited to leafy greens and wouldn't be appropriate for all commodities," Johanson said. "Also, that many existing water sources used for irrigation and crop protection wouldn't meet that standard. In the updated supplemental proposed rule, we are proposing to add flexibility, where one unusually high sample would not cause the water to be unusable."

She said new provisions would allow additional flexibility to achieve a microbial water standard by "accounting for water microbial die-off."

But Bob Blakely, vice president of California Citrus Mutual, said even with the revisions, he still had serious concerns about the water-quality language.

"It's almost more complicated now than it was before. There are people who should know how to interpret that language that are still confused, and I'm concerned how growers are going to be able to interpret that without having to go to the expense of hiring consultants or outside people to actually be able to comply with this rule," Blakely said.

According to FDA Deputy Commissioner for Foods and Veterinary Medicine Mike Taylor, "This is probably the most difficult area in our rulemaking and it is representative of the challenge that we have in implementing this law generally."

Taylor told the gathering that "the whole effort of this rulemaking is to get that balance right," and encouraged people to provide specifics about the challenges that remain in comments filed before the comment period closes Dec. 15.

On another provision, Johanson said the FDA received feedback that a nine-month time interval between the application of raw manure and harvest of produce was too strict, even stricter than the standard under the National Organic Program. FDA has decided to postpone that part of the rule, to conduct research to set an appropriate time interval.

"Between now and that point, FDA will not object if a grower is using the NOP 90- and 120-day time intervals," Johanson said.

Another change related to raw manure is elimination of the 45-day time interval for compost use. FDA now proposes to bring that interval to zero days.

Related to domesticated and animal impact on produce, Johanson said, "Some stakeholders still believe that the proposed revisions could result in growers feeling compelled to build more fences and clear animal habitat." (See story.)

In the supplemental notice, the FDA states the produce rule would not authorize taking of endangered or threatened species, or require measures to destroy animal habitat or exclude animals from outdoor growing areas.

In the supplemental rules for produce and preventive controls, FDA addresses packing and holding of a farm's own raw agricultural commodities—known as RACs—or commodities grown by another farm.

"In the original rule, different requirements would have applied when a farm packed or hauled its own RACs than when the same farm packed or held RACs for produce grown on another farm," said Johanson, who added these activities would have triggered a registration and the farm would have become a mixed-type facility—and therefore subject to the preventive controls rule for packing and holding produce from another farm.

Due to the number of comments received, the FDA modified its definition of a farm to include establishments that pack or hold raw agricultural commodities that are grown or raised on another farm, thereby moving this activity out of the preventive controls rule and under the produce rule.

Jenny Scott, senior advisor at the FDA Office of Food Safety, outlined revisions pertaining to how certain terms are defined—including a farm, holding, and "very small businesses"—and about other changes such as the framework for hazard analysis and risk-based preventive controls, product testing and environmental monitoring, a supplier verification program, economically motivated adulteration and withdrawal of exemption.

"We did get a lot of useful comments that caused us to rethink where we ought to be with some of these issues," Scott said. "We've heard your comments about what farms do, and we've tried to modify the farm definition to the extent that is logical to do so to incorporate these as farm activities."

Activities that have been added under the farm definition include field coring of produce such as lettuce, and the cooling and packaging of produce regardless of farm ownership.